Well-Known Genus, Novel Method: A Post-Amgen Framework for Written Description & Enablement
Key Takeaways: Recent Federal Circuit decision draws a meaningful distinction between patents that claim a broad genus as the invention itself and those that claim a novel therapeutic method using...
FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases
Key Takeaway: The FDA is developing a “plausible mechanism framework” to facilitate approval of individualized therapies for the treatment of rare genetic diseases that currently face approval challenges. As discussed previously...
No Do-Overs: Voluntary Dismissal Does Not Reset Deadline for Stay
ASCENDIS PHARMA A/S v. BIOMARIN PHARMACEUTICAL INC. Before Lourie, Chen, and Stoll. Appeal from the United States District Court for the Northern District of California. Summary: A respondent in an...
Standing Still? Only if Injury-In-Fact Is Tied to the Claims at Issue
IRONSOURCE LTD. v. DIGITAL TURBINE, INC. Before Moore, Lourie, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: An appellant seeking to establish Article III standing based on...
Protaryx Receives FDA Approval for Transseptal Puncture Device
Protaryx Medical, a Maryland-based company dedicated to “minimally invasive left-heart interventional therapies,” announced that its Transseptal Puncture Device received 510(k) clearance from the FDA. Transseptal puncture is designed to enable access to...
Veteran Ventures Capital Announces Investment in Hybron Technologies as Hybron Technologies Closes $25M Seed Round
Key Takeaways: Hybron Technologies, a U.S. based Manufacturing company focused on lightweight composites for aerospace and defense applications, closes an oversubscribed $25M seed round. The increased need for domestic production...
IP Implications of NRC’s Proposed New Fast Lane for Licensing Reactor Designs Previously Approved by DOE or DOD
Key Takeaway: The NRC’s proposed streamlined DOE/DOD reactor licensing pathway includes public disclosure obligations that can constitute prior art to later filed patent applications, and that raise potential inventorship issues,...
Federal Circuit Review | March 2026
Software Claims Failed Alice Step One Where Purported Improvements Were Not Claimed In Trustees Of Columbia University v. Gen Digital Inc., Appeal No. 24-1243, the Federal Circuit held that software claims...
PTAB Update | March 2026
PTAB to Rehear Ex Parte Baurin: Revisiting the Interplay of Obviousness-Type Double Patenting and Patent Term Adjustment After Cellect and Allergan Daniel M. Mittelstein & Michael L. Fuller The PTO...
